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Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Amgen And AstraZeneca Tout Fresh Tezepelumab Data

Recently-submitted tezepelumab reduced the annualized asthma exacerbation rate by 86% in a subgroup of patients with severe, uncontrolled asthma and nasal polyps, according to data presented at the European Respiratory Society congress.

Takeda Sees Another Wave 1 Plan Come Crashing Down

The Phase III failure for pevonedistat in three rare blood cancer settings is the third setback for Takeda’s Wave 1 pipeline candidates this year. The NEDD8 inhibitor is still being studied in other settings.

When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

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